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    K Number
    K042118
    Device Name
    ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    2005-04-29

    (266 days)

    Product Code
    JRY
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    JRY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zeus Scientific, Inc. AtheNA Multi-Lyte EBV IgG Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, EBV-EA total and Recombinant EBNA-1) through the AtheNA Multi-Lyte System. The test system is intended to be used with these EBV IgG markers) along with anti-EBV VCA IgM to aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and diseases caused by EBV virus.
    Device Description
    Not Found
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